| (II) keep a perpetual inventory of controlled substances
and other drugs required to be inventoried under §291.17 of this
title, that are received and dispensed or distributed from each remote
site.
(ii) As specified in §291.17 of this title, a
provider pharmacy shall conduct an inventory at each remote site.
The following is applicable to this inventory.
(I) The inventory of each remote site and the provider
pharmacy shall be taken on the same day.
(II) The inventory of each remote site shall be included
with, but listed separately from, the drugs of other remote sites
and separately from the drugs of the provider pharmacy.
(c) Remote pharmacy services using telepharmacy systems.
(1) Purpose. The purpose of this section is to provide
standards for the provision of pharmacy services by a Class A or Class
C pharmacy in a healthcare facility that is not at the same location
as a Class A or Class C pharmacy through a telepharmacy system as
outlined in §562.110 of the Texas Pharmacy Act.
(2) Definitions. The following words and terms, when
used in this section, shall have the following meanings, unless the
context clearly indicates otherwise. All other words and terms shall
have the meanings defined in the Act or §291.31 of this title.
(A) Provider pharmacy--
(i) a Class A pharmacy that provides pharmacy services
through a telepharmacy system at a remote dispensing site or at a
healthcare facility that is regulated by this state or the United
States; or
(ii) a Class C pharmacy that provides pharmacy services
though a telepharmacy system at a healthcare facility that is regulated
by this state or the United States.
(B) Remote dispensing site--a location licensed as
a telepharmacy that is authorized by a provider pharmacy through a
telepharmacy system to store and dispense prescription drugs and devices,
including dangerous drugs and controlled substances.
(C) Remote healthcare site--a healthcare facility regulated
by this state or the United States that is a:
(i) rural health clinic regulated under 42 U.S.C. Section
1395x(aa);
(ii) health center as defined by 42 U.S.C. Section
254b;
(iii) healthcare facility located in a medically underserved
area as determined by the United States Department of Health and Human
Services;
(iv) healthcare facility located in a health professional
shortage area as determined by the United States Department of Health
and Human Services; or
(v) a federally qualified health center as defined
by 42 U.S.C. Section 1396d(I)(2)(B).
(D) Remote pharmacy service--The provision of pharmacy
services, including the storage and dispensing of prescription drugs,
drug regimen review, and patient counseling, at a remote site.
(E) Remote site--a remote healthcare site or a remote
dispensing site.
(F) Still image capture--A specific image captured
electronically from a video or other image capture device.
(G) Store and forward--A video or still image record
which is saved electronically for future review.
(H) Telepharmacy system--A system that monitors the
dispensing of prescription drugs and provides for related drug use
review and patient counseling services by an electronic method which
shall include the use of the following types of technology:
(i) audio and video;
(ii) still image capture; and
(iii) store and forward.
(3) General requirements.
(A) A provider pharmacy may provide remote pharmacy
services using a telepharmacy system at a:
(i) remote healthcare site; or
(ii) remote dispensing site.
(B) A provider pharmacy may not provide remote pharmacy
services at a remote healthcare site if a Class A or Class C pharmacy
that dispenses prescription drug orders to out-patients is located
in the same community, unless the remote healthcare site is a federally
qualified health center as defined by 42 U.S.C. Section 1396d(I)(2)(B).
For the purposes of this subsection a community is defined as:
(i) the census tract in which the remote site is located,
if the remote site is located in a Metropolitan Statistical Area (MSA)
as defined by the United States Census Bureau in the most recent U.S.
Census; or
(ii) within 10 miles of the remote site, if the remote
site is not located in an MSA.
(C) A provider pharmacy may not provide remote pharmacy
services at a remote dispensing site if a Class A pharmacy is located
within 22 miles by road of the remote dispensing site.
(D) If a Class A or Class C pharmacy is established
in a community in which a remote healthcare site has been located,
the remote healthcare site may continue to operate.
(E) If a Class A pharmacy is established within 22
miles by road of a remote dispensing site that is currently operating,
the remote dispensing site may continue to operate at that location.
(F) Before providing remote pharmacy services, the
telepharmacy system at the remote site must be tested by the provider
pharmacy and found to operate properly. The provider pharmacy shall
make the results of such testing available to the board upon request.
(G) A provider pharmacy which is licensed as a Class
C pharmacy is required to comply with the provisions of §§291.31
- 291.34 of this title and this section.
(H) A provider pharmacy can only provide pharmacy services
at no more than two remote dispensing sites.
(4) Personnel.
(A) The pharmacist-in-charge of the provider pharmacy
is responsible for all operations at the remote site including supervision
of the telepharmacy system and compliance with this section.
(B) The provider pharmacy shall have sufficient pharmacists
on duty such that each pharmacist may supervise no more than two remote
sites that are simultaneously open to provide services.
(C) The following duties shall be performed only by
a pharmacist at the provider pharmacy:
(i) receiving an oral prescription drug order for a
controlled substance;
(ii) interpreting the prescription drug order;
(iii) verifying the accuracy of prescription data entry;
(iv) selecting the drug product to be stored and dispensed
at the remote site;
(v) interpreting the patient's medication record and
conducting a drug regimen review;
(vi) authorizing the telepharmacy system to print a
prescription label at the remote site;
(vii) performing the final check of the dispensed prescription
to ensure that the prescription drug order has been dispensed accurately
as prescribed; and
(viii) counseling the patient.
(D) A pharmacy technician at the remote site may receive
an oral prescription drug order for a dangerous drug.
(5) Operational standards.
(A) Application to provide remote pharmacy services
using a telepharmacy system.
(i) A Class A or Class C pharmacy shall file a completed
application containing all information required by the board to provide
remote pharmacy services using a telepharmacy system.
(ii) Such application shall be resubmitted every two
years in conjunction with the renewal of the provider pharmacy's license.
(iii) On approval of the application, the provider
pharmacy will be sent a license for the remote site, which must be
displayed at the remote site.
(iv) If the average number of prescriptions dispensed
each day at a remote dispensing site is open for business is more
than 125 prescriptions, as calculated each calendar year, the remote
dispensing site shall apply for a Class A pharmacy license as specified
in §291.1 of this title (relating to Pharmacy License Application).
(B) Notification requirements.
(i) A provider pharmacy shall notify the board in writing
within ten days of a discontinuance of service, or closure of a remote
site where a telepharmacy system is operated by the pharmacy.
(ii) A provider pharmacy shall comply with appropriate
federal and state controlled substance registrations for each remote
site, if controlled substances are maintained.
(iii) A provider pharmacy shall file a change of location
and/or name of a remote site as specified in §291.3 of this title.
(C) Environment/Security.
Cont'd... |
